Monthly Archives: October 2012

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For more than two decades, October has served as a time for us to honor and remember those affected by breast cancer, a disease that strikes almost a quarter of a million women every year and kills more than 35,000 each year. We’ve likely all known someone who has been touched by this disease. Fortunately, as we recognize another Breast Cancer Awareness Month, we can be heartened by signs of progress in combating this disease.

Recently, researchers announced they had identified four distinct types of breast cancer, information that could fundamentally reshape our scientific understanding of this disease. It could help explain why a drug therapy for one type of cancer may not work for another. The very real possibility that these findings—the product of a federal project called the Cancer Genome Atlas—will lead to new treatments is among the best news I’ve heard this year.

And there’s much more work going on. The fact is that scientists in the federal government, academia, and industry and patient groups and patients are making supreme efforts to make cancer, if not curable in all cases, at least a treatable, chronic disease. Today, 40 percent of all drug development is in cancer research, and a significant part of that work is focused on breast cancer. At FDA, we’re proud that our experts contribute to this crusade by providing invaluable guidance to researchers and companies that are developing drugs as well as diagnostic and treatment devices for cancer.

Thanks to these many efforts, physicians have a steadily increasing number of therapies and tools to use in confronting breast cancer. In the last two years, our agency has added three drugs to the 16 previously approved treatments for late-stage breast cancer and approved two state-of-the-art tools for screening and detecting breast cancer in its earliest stages, when it is most treatable.

One of these devices, which was approved last year, is the first X-ray device that provides three-dimensional images of the breast, a level of detail that may help the examining doctor make a more accurate diagnosis, which could lead to more successful treatments and spare the need for additional tests for many women.

And just a few weeks ago, FDA approved the first ultrasound device that can be used together with standard mammography to check dense breasts for early signs of cancer. This is an important advance for those women with dense breasts, who account for about 4 in 10 women who undergo mammography. Their dense breast tissue had been difficult to examine, putting these women at risk for late detection of breast cancer when the disease is difficult to treat.

FDA is involved in cutting-edge breast cancer research, working closely with outside scientists to help identify and develop promising new treatments. One major effort is to develop individualized therapies focused on the genetic make-up of specific breast tumors. Our agency is cooperating with scientists in the National Institutes of Health, academia and industry in an innovative study that could expedite the development of more tailored treatments for breast cancer. Patients with breast cancer are already among the earliest benefactors of the efforts towards targeted or personalized treatments, and more are in the works.

Breast cancer patients are playing a significant role in this broad-based, many-faceted effort to defeat cancer. Patients who participate in research are the backbone of scientific advances, because only through careful and systematic analysis of their disease can progress be made. Breast cancer patients are serving as patient representatives, playing an important role as members of advisory committees that help us to evaluate new drugs. They also provide essential information on what level of risks patients are willing to accept in order to gain access to potentially beneficial drugs.

While progress was made during the last two decades, a tremendous amount of work remains. I am confident, however, that through continued engagement with patients, the health professional community, academia and industry, breast cancer patients will have a wider range of available diagnostics and therapies, taking us one step closer to identifying a cure.

Margaret Hamburg, M.D., is Commissioner of the U. S. Food and Drug Administration

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